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Completed
NCT05762198
Comparing Water Vapour Thermal Therapy (Rezūm) and TURP
Conditions: Prostate Cancer
Sex: Male
Ages: 50 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 108
Sponsor: Chinese University of Hong Kong
Location: Prince of Wales Hospital, Chinese University of Hong Kong Hong Kong
Summary
This is a randomized controlled trial using a non-inferiority design with the subjects randomized 1:1 to either water vapour thermal treatment (REZUM) arm or transurethral resection of prostate (TURP) arm.
Eligibility Criteria
Inclusion Criteria:
* Men 50-80 years
* Refractory urinary retention related to benign prostatic hyperplasia (BPH)
* On urethral Foley's catheter before treatment
* Prostate size 30-80ml on ultrasound
Exclusion Criteria:
* Prior prostate operation
* Past or current history of prostate cancer
* Strong suspicion of prostate cancer (e.g. Elevated PSA before urinary retention or abnormal prostate on DRE without workup for prostate cancer)
* Known Urethral stricture / Bladder stone / Hypocontractile bladder
* Known neurological diseases which may affect bladder function (e.g. Parkinsonism, stroke)
* Contraindicated to undergo TURP or REZUM (e.g. not fit for GA/SA, active urinary tract infection, fail to be placed in lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped)
Source: ClinicalTrials.gov (NCT05762198). StuddyBuddy aggregates publicly available trial information.